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End-Stage Renal Disease Intra-dialysis Lifestyle Education Study (END-IDLE)

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ClinicalTrials.gov Identifier: NCT02361268
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gurjeet Birdee, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to compare the effects of intra-dialysis yoga to an educational program among patients with end-stage renal disease. The investigators hypothesize that yoga as compared to the educational program will significantly improve quality of life.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Behavioral: Intradialysis-yoga Behavioral: Educational program Not Applicable

Detailed Description:
The investigators propose a prospective, randomized clinical trial among on maintenance hemodialysis to compare the effects of intra-dialysis yoga to an educational program. In a sample of 68 patients the investigators will compare the clinical effects of a 12-week program of yoga to a 12-week education program during dialysis. Outcome assessment of study participants will occur at baseline, 6-weeks, 12-weeks, and 24 weeks for: disease-related quality of life (physical component primary outcome of the study), physical performance, blood pressure, fatigue, satisfaction with dialysis, sleep quality, and mood. Among a sub-sample of 20 participants, the investigators will measure the potential effects of the interventions on endothelial function, arterial stiffness, and autonomic tone. The sub-study will collect outcomes at baseline and 12 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intra-dialysis yoga
The experimental intervention in this study is intra-dialysis yoga.
Behavioral: Intradialysis-yoga
The experimental intervention in this study is intra-dialysis yoga. The intra-dialysis yoga protocol consists of yoga instruction and practice being offered three times a week for 12 weeks. Subjects will have the opportunity to participate in 15 to 60 minutes of yoga during dialysis.

Active Comparator: Educational program
The active comparator for the study is an educational program.
Behavioral: Educational program
The educational intervention in this study consists of 12 modules of an educational course, Kidney School, developed and maintained by the Medical Education Institute, Inc. Kidney School is a comprehensive, free, educational curriculum for people with kid




Primary Outcome Measures :
  1. Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks. [ Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks ]
    The Kidney Disease Quality of Life-36 instrument is a 36-item instrument that contains a generic core (Short Form-12) plus the burden of kidney disease, symptoms/problem of kidney disease, and effects of kidney disease scales.


Secondary Outcome Measures :
  1. Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: Baseline, 6, 12, and 24 weeks ]
    Questionnaire to assess fatigue among chronic disease patients

  2. Profile of Mood States [ Time Frame: Baseline, 6, 12, and 24 weeks ]
    Questionnaire to assess emotional states

  3. Center for Epidemiological Studies Depression [ Time Frame: Baseline, 6, 12, and 24 weeks ]
    Questionnaire to assess depressive symptoms

  4. End-stage renal disease: Patient satisfaction [ Time Frame: Baseline, 6, 12, and 24 weeks ]
    Questionnaire to assess patient satisfaction with dialysis treatment

  5. Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 6, 12, and 24 weeks ]
    Questionnaire to assess sleep quality

  6. Self-efficacy for self-management [ Time Frame: Baseline, 6, 12, and 24 weeks ]
    Questionnaire to assess self-efficacy for self-management

  7. 6-minute walk test [ Time Frame: Baseline, 12, and 24 weeks ]
    Assessment of physical performance

  8. Blood pressure [ Time Frame: Baseline and weekly over 12 week study period ]
  9. Measure of endothelial function with flow-mediated vasodilatation [ Time Frame: Baseline and 12-weeks ]
    Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters

  10. Measure of arterial stiffness from radial artery based pulse wave analysis [ Time Frame: Baseline and 12-weeks ]
    Sub-set of patient will have this assessment of arterial stiffness as augmentation index

  11. Autonomic tone [ Time Frame: Baseline and 12-weeks ]
    Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Maintenance hemodialysis for ≥3 or months
  • Adequately dialyzed (Kt/V ≥1.2 measured within last 3 months)
  • Expected to remain in present hemodialysis shift for next 4 months
  • Expected to remain on hemodialysis for at least 6 months
  • 18 years or older

Exclusion Criteria:

  • Acute or chronic medical conditions that would make intra-dialysis yoga potentially hazardous
  • Unstable cardiac disease e.g. angina, life threatening arrhythmia
  • Chronic lung disease that prevents gentle exercise or deep breathing exercises
  • Active cerebrovascular disease
  • Major depression
  • Chronic symptoms of nausea, vomiting, or diarrhea
  • Current participation in exercise or mind body program/practice
  • Cognitive impairment (MME ≤ 24) measured at baseline testing visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361268


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Gurjeet S Birdee, MD MPH Vanderbilt University Medical Center

Responsible Party: Gurjeet Birdee, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02361268     History of Changes
Other Study ID Numbers: 141325
K23AT006965 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Gurjeet Birdee, Vanderbilt University Medical Center:
end-stage renal disease
hemodialysis
yoga
mind-body medicine
meditation

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency